Alunbrig is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Alunbrig is used to treat non-small cell lung cancer that has spread to other parts of the body (metastatic).

Alunbrig is used only if your cancer has a specific genetic marker (an abnormal "ALK" gene). Your doctor will test you for this gene.

Alunbrig can cause serious side effects such as lung problems, vision problems, high blood pressure, high blood sugar, very slow heartbeats, muscle damage, or pancreatitis.

Call your doctor at once if you have side effects, such as: severe headache, confusion, feeling light-headed, blurred vision, seeing flashes of light or "floaters" in your vision, increased thirst or urination, hunger, nausea, upper stomach pain spreading to your back, unexplained muscle pain or weakness, fever, cough, chest pain, trouble breathing, very slow heartbeats, or feeling like you might pass out.

Take Alunbrig exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Alunbrig is usually taken once per day, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking Alunbrig, do not take another dose. Stay on your regular schedule.

Your blood pressure will need to be checked often.

You should not stop using this medicine unless your doctor tells you to.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Non-Small Cell Lung Cancer:

-Initial Dose: 90 mg orally once a day for the first 7 days
-Maintenance Dose: If initial dose is tolerated during the first 7 days, increase to 180 mg orally once a day.
-Duration of Therapy: Until disease progression or unacceptable toxicity

Use: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

You should not use Alunbrig if you are allergic to brigatinib.

To make sure Alunbrig is safe for you, tell your doctor if you have ever had:

• lung disease or breathing problems;

• slow heartbeats;

• high blood pressure;

• vision problems;

• diabetes or glucose intolerance;

• pancreas problems;

• liver disease; or

• kidney disease (or if you are on dialysis).

You may need to have a negative pregnancy test before starting this treatment.

Brigatinib can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, do not use this medicine if you are pregnant. Alunbrig can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using Alunbrig, use an effective non-hormonal form of birth control such as an intrauterine device (IUD). Avoid getting pregnant for at least 4 months after your last dose.

• If you are a man, use condoms or other barrier birth control if your sex partner is able to get pregnant. Keep using condoms for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using brigatinib.

Alunbrig may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because brigatinib can harm an unborn baby.

You should not breastfeed while using this medicine, and for at least 1 week after your last dose.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with brigatinib and lead to unwanted side effects. Avoid the use of grapefruit products.

This medicine may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Get emergency medical help if you have signs of an allergic reaction to Alunbrig: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• lung problems - cough, trouble breathing, chest pain, fever;

• vision problems - blurred vision, double vision, increased sensitivity to light, seeing flashes of light or "floaters" in your vision;

• high blood pressure - severe headache, pounding in your neck or ears, dizziness;

• high blood sugar - increased thirst, increased urination, hunger, nausea, fruity breath odor, weakness, confusion;

• heart problems - very slow heartbeats, feeling like you might pass out;

• muscle problems - unexplained muscle pain or weakness; or

• pancreatitis - upper stomach pain (worse with eating and may spread to your back), nausea, weight loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Alunbrig side effects may include:

• nausea, vomiting, diarrhea;

• increased blood pressure;

• trouble breathing;

• cough;

• rash;

• muscle pain;

• headache; or

• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with brigatinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.